FDA.reportPublic FDA data

HydroScreen

Product NDC
87110-005
11-digit product format
871100005
Labeler code
87110
Product ID
87110-005_4c9d5dfd-d791-fffc-e063-6294a90a4d30
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Octocrylene, Avobenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
METHODIQ INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-01
Substance
OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
48; 45; 120; 28 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
HydroScreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE48 mg/mL
OCTOCRYLENE45 mg/mL
HOMOSALATE120 mg/mL
AVOBENZONE28 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c9d5dfd-d790-fffc-e063-6294a90a4d30Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87110-005-01HydroScreen10 mL in 1 TUBECREAM101
87110-005-01HydroScreen1 in 1 CARTONCREAM11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 19 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Not there spf broad spectrum spf40 moisturizerAVOBENZONE 3% ,HOMOSALATE 10% ,OCTISALATE 5% ,OCTOCRYLENE 8% ,ZINC OXIDE 4%Foshan Sugar Max Cosmetics CO.,Ltd546f0474-4102-26d0-e063-6394a90a388b2026-06-17WarningsExact identifier
application number: M020
Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40ZINC OXIDEGrace and Fire USA Inc.52d4b1c1-7431-4f8c-e063-6294a90ad4822026-06-17WarningsExact identifier
application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF30ZINC OXIDEMoes Group LLC54751f23-5723-0407-e063-6294a90a4a962026-06-17WarningsExact identifier
application number: M020
Amber Sunglaze Sheer Body Mist Sunscreen SPF30AVOBENZONE, OCTISALATE, OCTOCRYLENEKoco Life LLC5478fb36-e972-f824-e063-6294a90a567f2026-06-17WarningsExact identifier
application number: M020
Elaine Sterling Hydrating SunscreenZINC OXIDEElaine Sterling Enterprises5479e862-aca5-7541-e063-6394a90ad0c52026-06-17WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS545aa56a-ed07-acd6-e063-6394a90ae0c72026-06-16WarningsExact identifier
application number: M020
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREENOCTISALATELOreal USA Products Inc3b99ab06-ba4c-4ddd-a057-60028eedd67d2026-06-16WarningsExact identifier
application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREENZINCOXIDEMoes Group LLC54617bf2-1d8d-531e-e063-6294a90a70802026-06-16WarningsExact identifier
application number: M020
Daily Defence Mineral Sunscreen SPF 50 Fragrance FreeZINC OXIDEUltraceuticals Pty Ltd5461ee82-0297-ce22-e063-6294a90a729b2026-06-16WarningsExact identifier
application number: M020
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
application number: M020
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
application number: M020
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC546b0702-a3cc-fd6f-e063-6394a90af8492026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 30ZINC OXIDEWhole Foods Market, Inc.5ce712d6-cafd-4a80-9f8c-2149fdebff542026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 50ZINC OXIDEWhole Foods Market, Inc.1f8387be-d871-435b-baef-e537c67a510a2026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 50OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND HOMOSALATEWhole Foods Market, Inc.82771f22-0197-40ba-97d2-2386152790ed2026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWhole Foods Market, Inc.1c31f466-6a0d-46ce-9346-d2a0eb46c8d02026-06-15WarningsExact identifier
application number: M020
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
application number: M020
Solvyn Mineral Sunscreen SPF 50ZINC OXIDESolvyn Skin LLCb0a8d028-87d2-4339-8879-c62cbf8415f22026-06-15WarningsExact identifier
application number: M020
Amrit Ocean Resort Mineral Sunscreen SPF 50ZINC OXIDESolvyn Skin, LLC112364cd-a445-46c2-b2f3-f9705d682cf62026-06-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87110-005-01871100005011 TUBE in 1 CARTON (87110-005-01) / 10 mL in 1 TUBE1 tube2026-04-01NoNoCurrent